A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

- Male and female patients, 18 to 75 years when signing informed consent at screening
- Established diagnosis of clinical CD prior to screening
- Suspicion of symptomatic small bowel stenosis
- Presence of abdominal pain after eating or limitation in amount or types of food at screening
- 1 or 2 naïve or anastomotic stenoses in the terminal ileum at screening, confirmed by MRE at randomization
- Have achieved Symptomatic Stenosis Response before randomization (i.e. 7 day average scores <2 for diary questions on the abdominal pain after eating AND on the limitation in amount or types of food)
- Endoscopic activity defined by Colonic Simple Endoscopic Score in CD (SES-CD) =12 after Lead-in Period, at the time of randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- No stenosis in reach of ileocolonoscopy
- Systemic corticosteroid treatment of current obstructive symptoms for >1 week prior to screening
- Endoscopic balloon dilation (EBD) or surgical treatment of the same small bowel stenosis within the last 6 months prior to screening Visit 1
- More than 2 smal intestinal stenoses
- Patients who require immediate EBD or surgical intervention as per the investigator´s discretion
- Failure of >2 different biological drug classes prior to screening (e.g. TNF inhibitors, Integrin Receptor antagonists and
IL-12 / IL-23 antagonists)
- Current complications of CD at screening Visit 1 and randomization (Day 1) that would possibly confound the evaluation of benefit from treatment with spesolimab
- Current stenosis in the colon
- Previous strictureplasty on current stricture
- Current ileostomy or colostomy
- Any kind of bowel resection or diversion within 6 months of screening Visit 1
- Any other intra-abdominal surgery (except for abscess drainage) within 3 months prior to screening Visit
- Colorectal cancer (CRC) present and past (<5 years) history

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Response and/or inducing Radiographic Stenosis Response in patients with symptomatic CD-related small bowel stenosis, who have achieved Symptomatic Stenosis Response after standard medical therapy.;Secondary Objective: Not applicable;Primary end point(s): 1) Proportion of patients with maintained Symptomatic Stenosis Response<br>2) Proportion of patients with Radiographic Stenosis Response ;Timepoint(s) of evaluation of this end point: 1) Week 48<br>2) Week 48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Proportion of patients with maintained Symptomatic Stenosis Response<br>2) Proportion of patients with Radiographic Stenosis Response<br>;Timepoint(s) of evaluation of this end point: 1) Week 24<br>2) Week 24<br>

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